ATMA Submits N500 MDMA Phase II Clinical Trial Application to Health Canada

Published: Apr. 13, 2023 at 7:30 AM EDT|Updated: 1 hour ago

Designed to mirror ATMA’s Health Canada approved N500 Phase II Psilocybin Clinical Trial for frontline healthcare professionals

Calgary, AB, April 13, 2023 /PRNewswire/ – ATMA Journey Centers Inc. (“ATMA”), Canada’s leading psychedelic-assisted therapy training provider, is pleased to announce it has submitted an N500 3,4-Methylenedioxymethamphetamine (MDMA) phase II Clinical Trial Application (CTA) to Health Canada, which aims to assess the efficacy of MDMA in treating mental health issues in frontline healthcare workers, as well as to provide subjective documentation of its clinical utility. This will be the largest MDMA clinical trial to date.

Often overlooked, healthcare professionals suffer from psychological trauma, anxiety, depression, and burnout in parallel with the general population. However, evidence shows that they experience these mental health concerns to a much larger extent than the general public due to the nature of their frontline work on a daily basis. From compassion fatigue to vicarious traumatization, as well as personal mental challenges, frontline healthcare workers have learned a great deal to suppress their suffering and attempt to function with it in their daily lives. Indeed, many frontline healthcare workers have unknowingly adapted to burnout. One of ATMA’s mandates is to assess the clinical efficacy of psychedelic medicine in treating these mental health issues.

It is anticipated ATMAs Health Canada-approved phase II psilocybin trial will commence in the summer of 2023. As ATMA’s first cohort of 80+ graduates nears completion of the Advanced Psychedelic-Assisted Therapy Training course, students are excited about the prospect of participating in this trial, in which enrollment will commence upon approval from the Health Research Ethics Board of Alberta (HREBA). The N500 clinical trial has the primary objective of examining the efficacy of psilocybin in the treatment of Generalized Anxiety Disorder, Major Depressive Disorder, and Occupational Burnout Syndrome in frontline healthcare professionals who have been negatively impacted by stressful work conditions as a result of COVID-19 . The secondary objective of this study will provide insights on the utility of this medicine as a therapeutic tool from the perspective of healthcare professionals interested in this field of work.

While psilocybin may be effective in treating the aforementioned mental health issues, MDMA too may be an alternative therapeutic agent. US Australia moves towards the legalization of both psilocybin and MDMA for clinical use, and with Canada likely to follow suit, there is a clear need for a large scale MDMA clinical trial; this is essential in order to provide the necessary data to support clinical implementation and protocol development, as well as to offer healthcare professionals the opportunity to gain a better understanding of the utility of MDMA as an adjuvant therapeutic agent, in the same manner as psilocybin.

ATMA’s phase II MDMA trial is very similar to their N500 psilocybin trial; frontline healthcare workers with documented mental health issues will undergo pre- and post-treatment self-administered psychological assessments to document the efficacy of MDMA as a therapeutic agent. Additionally, ATMA will be collecting feedback from participants on the potential clinical utility of MDMA. A tertiary outcome of the trial will be the experience of observing other participants who are under the effects of MDMA, which may help healthcare workers understand how MDMA-assisted therapy could be beneficial in a legal, clinical setting.

“We are excited to begin collecting data and hearing the perspective of healthcare professionals participating in our clinical trials using putative psychedelic therapeutics,” states Dr. Ravi Bains, ATMA’s Chief Medical Officer. “To then be able to compare the data and experiences of healthcare professionals undergoing psilocybin versus MDMA treatment for similar indications will be crucial to determining the clinical utility of these compounds.” “We believe that the data coming out of these clinical trials will be invaluable to both the development of this field and our community of psychedelic practitioners,” states Vu Tran, Founder of ATMA. “Practitioners sharing their personal experiences with their peers will also help to innovate best practices and establish sound protocols for the effectiveness of psychedelic-assisted therapy.”

“As psychedelic-assisted therapy nears legal status globally, Health Canada will be seen by the world as a progressive leader in psychedelic medicines, for making these types of clinical trials available to healthcare professionals who are training in this field,” Tran adds. “As a result, more effective practitioners and leaders will emerge in the Canadian psychedelic industry.”

ATMA’s programs and trials are open to international healthcare professionals who meet the exclusion and inclusion criteria. Graduates of MAPS, CIIS, and other qualifying advanced psychedelic programs are also welcome.

We care about improving the lives and practices of healthcare professionals.
ATMA is pioneering a health practitioner business model for the psychedelic industry. Education, training, clinical trials, and business support services are all being developed for the largest community of psychedelic practitioners, to assist mental healthcare professionals in adopting psychedelic-assisted therapy into their practices. ATMA provides a clear, guided path for healthcare professionals and clinics to navigate through this process.

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SOURCE ATMA Journey Centers Inc

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